Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-06 @ 8:05 AM
Study NCT ID:
NCT04930133
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 737}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-06-13', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total TOT', 'timeFrame': "Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).", 'description': 'the time on treatment (total TOT) of EGFR M+ NSCLC patients treated with afatinib in the first-line (TOT-1) followed by second line treatments(TOT-2) including osimertinib, chemotherapy and other treatments.'}], 'secondaryOutcomes': [{'measure': "objective response rate (ORR-1 & ORR-2's)", 'timeFrame': "Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30)."}, {'measure': 'overall survival time', 'timeFrame': "Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T790', 'afatinib'], 'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while \\> 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'non-interventional, multi-center, multi-cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than 18 years\n2. Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)\n3. Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.\n\nExclusion Criteria:\n\n1. Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment\n2. Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A\''}, 'identificationModule': {'nctId': 'NCT04930133', 'briefTitle': 'Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Totality Outcome of Afatinib Sequential Treatment in Patients With EGFR Sensitizing Mutation-positive NSCLC in South Korea', 'orgStudyIdInfo': {'id': 'TOAST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'T790M+ patients sequentially treated with osimertinib in cohort A', 'interventionNames': ['Drug: Gilotrif']}, {'label': 'Cohort B', 'description': 'T790M- patients treated with chemotherapy or other treatments in cohort B', 'interventionNames': ['Drug: Gilotrif']}, {'label': 'Cohort C', 'description': 'patients with unknown mutation status in cohort C', 'interventionNames': ['Drug: Gilotrif']}, {'label': 'Cohort D', 'description': 'Cohort D included patients who were still ongoing with afatinib.', 'interventionNames': ['Drug: Gilotrif']}], 'interventions': [{'name': 'Gilotrif', 'type': 'DRUG', 'description': 'This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C', 'Cohort D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jin Hyoung Kang', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin Hyoung Kang', 'role': 'STUDY_CHAIR', 'affiliation': "Seoul St. Mary's Hospital, The Catholic University of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Medical Oncology, Department of Internal Medicine', 'investigatorFullName': 'Jin Hyoung Kang', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}